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Job Description AM Engineering Project

Function: Engineering Projects & Automation (Global Technical Operation)
Grade: (Pay Grade 26)
Reporting to: Engineering Project Manager

Role Purpose

AM Engineering Project Automation & Machine Building is responsible for endtoend execution of engineering automation and custom machinebuilding projects working closely with global OEMs machine builders and system integrators.

The role combines strong project management discipline (PMP preffered) deep automation and controls expertise and handson machine realization experience to deliver safe compliant and highperformance manufacturing equipment in a regulated environment.

Key Responsibilities

Project Management & Capital Execution

• Lead automationdriven engineering and machinebuilding projects from user requirements through design FAT SAT commissioning qualification and handover.

• Own project scope schedules budgets risks and change management.

• Ensure delivery meets safety quality compliance cost and timeline commitments.

• Apply standardized project management methodologies for capital projects.

Machine Building & Global Vendor Management (Mandatory)

• Act as technical project owner for custombuilt machines and automated systems.

• Work directly with global machine suppliers OEMs and system integrators during: Concept and detailed design Machine build and integration FAT at vendor sites (global) Installation SAT rampup and handover

• Review and approve mechanical electrical automation and software design deliverables.

• Ensure supplier compliance with safety quality validation and J&J engineering standards.

Automation Controls & Programming

• Provide strong technical leadership and/or handson expertise in: PLC systems (ladder logic / structured text) HMI / SCADA development Servo drives VFDs motion control Machine safety systems

• Lead automation troubleshooting logic review performance tuning and optimization.

• Ensure automation solutions are robust standardized and scalable.

Vision Systems & Advanced Automation

• Lead integration of Cognex (or equivalent) vision systems for inspection verification and traceability.

• Define vision system requirements acceptance criteria and commissioning strategy.

• Support longterm system reliability and performance.

Electrical & Instrumentation Engineering

• Review and approve electrical schematics panel layouts loop diagrams and instrumentation selection.

• Ensure compliance with electrical codes functional safety and regulatory standards.

• Coordinate electrical installation testing and commissioning activities.

Compliance Validation & Governance

• Ensure projects comply with EHS machine safety GMP Quality Systems and Data Integrity requirements.

• Lead or support IQ / OQ / PQ execution for automated equipment.

• Own deviations root cause investigations and CAPA implementation related to automation or equipment.

• Maintain auditready project and validation documentation.

Stakeholder & Team Leadership

• Coordinate with Manufacturing Quality Validation IT/OT Supply Chain Procurement and Global Engineering teams.

• Provide technical mentoring and task leadership to junior engineers or automation resources.

• Communicate project progress risks and mitigation plans to engineering leadership.

Compliance Knowledge Requirements

Demonstrated working knowledge and practical application of:

• Machine Safety & Functional Safety: ISO 12100 ISO 13849 (Cat / PL) IEC 62061 ISO 13857 ISO 14119 ISO 14120

• Electrical Safety: IEC 602041

• Automation Standards: IEC 611313 industrial networks safety PLC concepts

• Medical Device & Quality: ISO 13485 FDA 21 CFR Part 820 principles

• GMP & Data Integrity: EU GMP Annex 15 ICH Q7/Q9/Q10 concepts ALCOA 21 CFR Part 11 awareness

• Equipment Qualification: IQ OQ PQ; riskbased validation; controlled FAT/SAT with vendors

• Internal Standards: J&J Machine Safety / ZeroAccess (ZAMG) and risk assessment practices

Qualification & Experience

• Degree in Electrical / Electronics / Instrumentation / Automation Engineering (preferred).

• Strong experience in automationintensive machinebuilding or capital projects.

• Mandatory handson exposure to: Global machine vendors / OEMs PLC HMI servo drives Cognex or equivalent vision systems Automation programming and integration

• Experience in regulated manufacturing (MedTech / Pharma) preferred.

• Ability to find root cause through QMS driven approach & awareness of CAPA Process

Role Positioning

• This role is handson technical execution leadership role.

• Expected to operate independently with minimal supervision.

Required Skills:

Preferred Skills: